Sterile water dispersion system for allograft preparation and processing

ABSTRACT

There is disclosed a system and method for dispersing sterile water from a circulating high-purity water system to a processing field containing allograft tissue. One embodiment includes a fluid inlet that is fluidly coupled with and configured to receive sterile water from the water system. The dispersion system also includes at least first and second fluid outlets that are selectively operable to deliver respective first and second fluid streams into different areas of the processing field. At least one of the first and second fluid outlets may be associated with a regulator valve configured to provide an adjustable flowrate to conserve water pulled from the circulating water system to meet the needs of the application taking place within the processing field. Other embodiments are also disclosed.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/259,376, filed Sep. 8, 2016 by Donald Von Kaenel, et al. for “STERILEWATER DISPERSION SYSTEM FOR ALLOGRAFT PREPARATION AND PROCESSING” whichclaims the benefit under 35 U.S.C. 119(e) of U.S. Provisional PatentApplication No. 62/256,438, filed Nov. 17, 2015 by Donald Von Kaenel andDaniel R. Hanten II for “STERILE WATER DISPERSION SYSTEM FOR ALLOGRAFTPREPARATION AND PROCESSING,” which patent application is herebyincorporated herein by reference.

BACKGROUND

An allograft includes bone, tendon, skin, or other types of tissue thatis transplanted from one person to another. Allografts are used in avariety of medical treatments, such as knee replacements, bone grafts,spinal fusions, eye surgery, and skin grafts for the severely burned.Allografts come from voluntarily donated human tissue obtained fromdonor-derived, living-related, or living-unrelated donors and can helppatients regain mobility, restore function, enjoy a better quality oflife, and even save lives in the case of cardiovascular tissue or skin.

Allograft processing centers are generally responsible for processingand cataloging allografts collected by organ procurement organizations(“OPOs”). The OPOs are, in turn, responsible for collecting and/orrecovering voluntarily donated tissues and gathering any pertinentmedical information about those tissues before transferring them to theprocessing center.

Once an allograft is received, the allograft processing center is thenresponsible for processing the allograft and readying it for safe andeffective medical use. Such processing may involve several stepsincluding inspection, testing, cleansing, and cataloging, all performedin government-certified (or equivalent) laboratories and subject tostrict standards and regulations. To render the risk of diseasetransmission extremely remote, allograft tissue is processed toeliminate risk of infection transmission and tissue rejection. Graftsare sterilized and tissues are carefully preserved in an effort toretain the original structural and biological integrity of the graft.Quality assurance checks are incorporated into the preparation process,including aerobic and anaerobic cultures and any applicable additionaltesting.

Careful steps must be taken to ensure sterile integrity throughout thepreparation process discussed above. In this regard, an allograftprocessing center often utilizes a high-purity water system thatcirculates sterile water throughout the processing center to each of thelaboratories (e.g., clean rooms) used in the preparation process. Usingthis type of “loop” circulation system, sterile water that meets definedmicrobial limits is typically delivered via a distribution line to theprocessing field. Water is then returned as feed to the distillationand/or filtration system via a feedback loop for sterilization andreentry into the distribution line.

Loop water systems are effective at transporting water to the sterileenvironment, but they are expensive to operate. Every gallon of sterileinjection water consumed comes at a cost, and, therefore, exercisingcontrol over water dispersal is paramount.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key aspects oressential aspects of the claimed subject matter. Moreover, this Summaryis not intended for use as an aid in determining the scope of theclaimed subject matter.

One embodiment provides a system for dispersing sterile water from acirculating high-purity water system into a processing field containingallograft tissue. The system may include a fluid inlet that is fluidlycoupled with and configured to receive sterile water from the watersystem. The system may also include at least first and second fluidoutlets, wherein the first and the second fluid outlets are selectivelyoperable to deliver respective first and second fluid streams to theprocessing field, and at least one of the first and the second fluidoutlets is configured to deliver fluid into the processing field at anadjustable flow rate.

Another embodiment provides a method of dispersing sterile water from acirculating high-purity water system to a processing field containingallograft tissue using a dispersal system having a fluid inlet fluidlycoupled with the water system and at least first and secondselectively-operable fluid outlets. The method may include activatingthe first fluid outlet to deliver a first fluid stream to a first areaof the processing field, wherein the first fluid stream comprises anunimpeded fall of the sterile water into the first area of theprocessing field. The method may also include adjusting a flow rate ofthe first fluid stream to achieve a desired flow rate of the first fluidstream exiting the first fluid outlet, and activating the second fluidoutlet to deliver a second fluid stream to a second area of theprocessing field.

Yet another embodiment provides a water dispersion system for dispersingsterile water from a loop water system into an allograft processingfield. The water dispersion system may include (1) a fluid inletconfigured to receive the sterile water from the loop water system; (2)a first fluid outlet configured to disperse a first fluid stream of thesterile water into a first area of the allograft processing field; and(3) a second fluid outlet configured to disperse a second fluid streamof the sterile water into a second area of the allograft processingfield. The first fluid outlet and the second fluid outlet are offsetfrom the allograft processing field, and the first fluid stream mayremain at all times fluidly separate from the second fluid stream.

Other embodiments are also disclosed.

Additional objects, advantages and novel features of the technology willbe set forth in part in the description which follows, and in part willbecome more apparent to those skilled in the art upon examination of thefollowing, or may be learned from practice of the technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention,including the preferred embodiment, are described with reference to thefollowing figures, wherein like reference numerals refer to like partsthroughout the various views unless otherwise specified. Illustrativeembodiments of the invention are illustrated in the drawings, in which:

FIG. 1 illustrates an exploded view of one embodiment of a waterdispersion system for dispersing sterile water from a loop water systeminto an allograft processing field in a variable and controlled manner;

FIG. 2 illustrates a perspective view of the water dispersion system ofFIG. 1, as installed above a processing field;

FIG. 3 illustrates a side view of one embodiment of a fluid inlet of thewater dispersion system of FIGS. 1-2;

FIG. 4 illustrates a perspective view of one embodiment of a first fluidoutlet of the water dispersion system of FIGS. 1-2;

FIG. 5 illustrates a perspective view of one embodiment of a regulatorvalve and flow rate-adjustment handle associated with the first fluidoutlet of FIG. 4;

FIG. 6 illustrates a perspective view of one embodiment of a secondfluid outlet of the water dispersion system of FIGS. 1-2; and

FIG. 7 provides a flowchart depicting an exemplary method of dispersingsterile water from a circulating high-purity water system using thewater dispersion system of FIGS. 1-2.

DETAILED DESCRIPTION

Embodiments are described more fully below in sufficient detail toenable those skilled in the art to practice the system and method.However, embodiments may be implemented in many different forms andshould not be construed as being limited to the embodiments set forthherein. The following detailed description is, therefore, not to betaken in a limiting sense.

Current mechanisms for dispersing water from a loop water system intothe processing field where allograft tissue preparation occurs (e.g.,into a beaker containing allograft tissue or in connection with othervessels and/or equipment containing or being exposed to allografttissue) do not allow processing personnel to disperse sterile water in avariety of controlled ways to aid in the thawing, cleaning, purging,and/or rinsing of donated tissue. For instance, current dispersionmechanisms provide for a singular flow stream having a set flow rate. Asingular flow stream results in lost efficiency due to the fact thattechnicians cannot multi-task while availing themselves of a single flowstream. A set flow rate leads to wasted water via unnecessarily highflow rates for certain applications. Further, current sterile-waterdispersion approaches generally allow water delivery equipment to comeinto close proximity or contact with the processing field, which risksthe backflow of microbes into the loop water system and puts the sterileintegrity of the allograft processing center at risk.

Various embodiments of the systems and methods described herein relateto controlling the dispersion of sterile water from a circulating orloop high-purity water distribution system (hereinafter a “loop watersystem” or “loop”) to a processing field containing human allografttissue in a manner that protects the loop water system from microbialcompromise. One embodiment provides a dispersion system that includes atleast two fluid outlets that may direct sterile water to different areaswithin the processing field. Because a variety of activities take placewithin the processing field (e.g., the thawing, cleaning, purging,and/or rinsing of donated tissue), multiple fluid outlets allow atechnician to multitask by directing one fluid stream to a first areawithin the processing field and another fluid stream to another areawithin the processing field. For example, a tissue sample may bearranged for continuous thawing beneath a first fluid stream, while thetechnician may take advantage of the second fluid stream tosimultaneously perform an array of alternate tasks. In addition, atleast one of the dispersion system's fluid outlets may be adjustable,thereby allowing the technician to control the water flow to achieve adesired flow rate, conserving up to hundreds of gallons of costlysterile water during a single processing session. Moreover, both fluidoutlets may be configured to prevent microbial wicking or travel fromthe processing field back into the loop water system, ensuring thesterile integrity of the processing center's water as a whole.

FIGS. 1-2 illustrate respective exploded and perspective views of oneembodiment of a water dispersion system 10 for dispersing sterile waterfrom a loop water system 11 into a processing field in a variable andcontrolled manner. In this embodiment, water dispersion system 10 mayinclude an inlet 12, which fluidly couples with and receives sterilewater from loop water system 11. Embodiments of inlet 12 may be formedof stainless steel and may take any appropriate size, shape, and/orconfiguration capable of fluidly coupling with loop water system 11. Inone embodiment, inlet 12 may be a commercially available quick-connectbody such as, for example, Swagelok Part No. SS-QC4-B-4PM.

FIG. 3 illustrates a side view of one embodiment of inlet 12. In thisembodiment, and as detailed in FIG. 1, inlet 12 may have a first end 14that directly connects to loop water system 11 and a second end 16 thatforms a male coupler configured to attach to a tee fitting 18. Teefitting 18 may be a tee-shaped stainless steel pipe fitting configuredto route sterile water between a first fluid outlet 20 and a secondfluid outlet 22. In one embodiment, tee fitting 18 may be a commerciallyavailable fitting such as, for instance, Swagelok Part No. SS-4-T.

FIG. 4 illustrates a side view of one embodiment of first fluid outlet20. In this embodiment, and as detailed in FIGS. 1 and 4, first fluidoutlet 20 may be a subassembly formed of serialized right-angle fittings24 (e.g., Swagelok Part No. SS-4-SE) and a single-threaded-end pipenipple 26 (e.g., McMaster-Carr Part No. 9110T11). As shown in FIG. 2,when water dispersion system 10 is connected to loop water system 11,pipe nipple 26 may be directed downward such that sterile water flowingfrom first outlet 20 cascades unimpeded in a downward direction in awaterfall-like manner into a first area 41 of a processing field 40.This type of free flow allows only water, rather than a hose or otherwater-delivery device, to come into contact with processing field 40,thereby preventing backflow, travel, and/or wicking of microbes upwardfrom processing field 40 and back into loop water system 11. Forexample, water may be directed from first fluid outlet 20 into a beakeror other vessel 45 containing allograft material without riskingcontamination of the loop's sterile water supply as a result ofmicrobial backflow from vessel 45, through the delivery hose, and upwardinto loop water system 11.

To allow for maximum user control over the sterile water flowing fromfirst fluid outlet 20, a regulator valve 28, detailed in FIGS. 1 and 5,may be connected between tee fitting 18 and first fluid outlet 20.Regulator valve 28 may be any appropriate valve having a size, shape,type, and/or configuration designed to allow for manual adjustment of aflow rate of sterile water through first fluid outlet 20. In oneembodiment, regulator valve 28 may be a subassembly formed of ahigh-purity, high-pressure angle-pattern valve 30 (e.g., Swagelok PartNo. SS-DSM4F4A) equipped with an anodized rotating handle 32. Regulatorvalve 28 may allow for a wide range of flow rates, depending upon theapplication occurring in the processing field. For example, at 100%,75%, 50%, and 25% open, regulator valve 28 may provide respective flowrates of 504 liters/hour, 396 liters/hour, 252 liters/hour, and 126liters/hour. This ability to adjust the flow rate gives the technicianmaximum flexibility in controlling the amount of water used and inlimiting water use to only that needed for a particular application,thereby significantly reducing the amount of sterile water pulled fromthe loop water system.

Returning to FIG. 1, beyond directing water to first fluid outlet 20,tee fitting 18 may also direct water to second fluid outlet 22, givingtechnicians a second usable water outlet that allows for multitaskingwithin the same processing field 40. In one embodiment detailed in FIGS.1 and 6, second fluid outlet 22 may be formed of a quick-connect stem(e.g., Swagelok Part No. SS-QC4-S-4PM) having a first end 34 that formsa male coupler configured to connect with tee fitting 18 and a secondend 36 configured to connect with a delivery hose 42. The delivery hosemay be directed to a second area 43 within processing field 40 (FIG. 2)than the flow from first fluid outlet 20, depending on the currentapplication, task, and/or needs of the technician. Further, flow and/orpooling of fluid from second fluid outlet 22 may be kept entirelyfluidly separate from the flow and/or pooling of fluid from first fluidoutlet 20, preventing crossover between the two streams.

To prevent contamination or microbial wicking through hose 42 connectedto second fluid outlet 22, the hose may be suspended—either manually, byusing a fixture, or by allowing the hose to hang freely—such that hose42 does not come into contact with water or the surfaces of tools and/orequipment that have been exposed to microbes of the allograft materialbeing processed within processing field 40. In one embodiment, the“open” hose 42 connected with second fluid outlet 22 (i.e., hose 42without a pressure tip) may provide a flow rate of 456 liters/hour.

This second fluid outlet 22 provides technicians with maximumflexibility in accomplishing varying tasks within a single processingfield. For example, a technician may perform a continuous thawing offrozen allograft tissue in conjunction with first fluid outlet 20, whilesimultaneously performing an array of tasks associated with processingthe human tissue and requisite equipment (e.g., cleaning, purging,rinsing, etc.) in conjunction with second fluid outlet 22. In performingthis variety of simultaneous tasks, the technician need not stop tochange nozzle tips, as the technician has flow-rate adjustable access toboth free flowing water from first fluid outlet 20 and the constrainedflow from hose 42, which is coupled with second fluid outlet 22.

While tee fitting 18 is described as a pipe fitting, some embodimentsmay incorporate a tee-valve that offers further regulation of flowacross first fluid outlet 20 and/or second fluid outlet 22, providingmaximum control over the dispersion of water from the loop.

Embodiments of water dispersion system 10 may also incorporate abackflow device (not shown). This device may have any appropriate size,shape, type and/or configuration to further inhibit microbial backflow.

Using water dispersion system 10, allograft preparation technicians mayemploy a preparation process that utilizes at least two water streamsand adjusts the flow of those streams to achieve maximum control, bothover where water is directed into the processing field and over how muchwater is directed into the processing field to meet the needs of thetasks at hand. All of this may be accomplished without riskingcontamination to the loop water system.

FIG. 7 depicts a flowchart detailing an exemplary method 50 ofdispersing sterile water from a circulating high-purity water system.Method 50 may initiate with activating first fluid outlet 20 to delivera first sterile fluid stream to a first area 41 of processing field 40(52). The method may continue with adjusting regulator valve 28 (54) toregulate a flow rate of the first fluid stream such that a desired flowrate exits first fluid outlet 20. The desired flow rate may be afunction of the task(s) to be performed in conjunction with the firststerile fluid stream. Method 50 may also include activating second fluidoutlet 22 (56) to deliver a second fluid stream to a second area 43 ofprocessing field 40. With both first and second fluid outlets activated,the technician may simultaneously perform (58) a first task in firstarea 41 of processing field 40 and a second task in second area 43 ofprocessing field 40.

Although the above embodiments have been described in language that isspecific to certain structures, elements, compositions, andmethodological steps, it is to be understood that the technology definedin the appended claims is not necessarily limited to the specificstructures, elements, compositions and/or steps described. Rather, thespecific aspects and steps are described as forms of implementing theclaimed technology. Since many embodiments of the technology can bepracticed without departing from the spirit and scope of the invention,the invention resides in the claims hereinafter appended.

What is claimed is:
 1. A system for dispersing water for allografttissue processing, comprising: a processing field containing allografttissue; a circulating high-purity water system; a sterile water flowthrough the circulating high-purity water system; a fluid inlet, thefluid inlet fluidly coupled with and configured to receive sterile waterfrom the water system; and at least one fluid outlet selectivelyoperable to deliver a fluid stream to the processing field containingallograft tissue, the at least one fluid outlet vertically offset adistance from equipment exposed to microbes of the allograft materialbeing processed within so as to prevent contamination and microbialwicking from the processing field to the circulating high-purity watersystem; and the at least one fluid outlet selectively operable todeliver fluid into the processing field at an adjustable flow rate. 2.The system of claim 1, wherein the at least one fluid outlet is adaptedto deliver the fluid stream to a first area of the processing field. 3.The system of claim 2, wherein the at least one fluid outlet isassociated with a regulator valve configured to achieve the adjustableflow rate in the fluid stream.
 4. The system of claim 2, wherein thefluid stream comprises an unimpeded fall of the sterile water into theprocessing field, thereby preventing microbial wicking from theprocessing field into the at least one fluid outlet.
 5. The system ofclaim 2, wherein the at least one fluid outlet comprises a quick-connectstem adapted for attachment to a fluid-delivery hose.
 6. The system ofclaim 1, wherein the at least one fluid outlet does not contact theprocessing field or the allograft tissue contained within the processingfield.
 7. The system of claim 1, wherein the fluid stream is at alltimes fluidly separate from a second fluid stream delivered by a secondfluid outlet.
 8. A water dispersion system, comprising: an allograftprocessing field; a loop water system operating in proximity of theallograft processing field; a flow of sterile water circulating throughthe loop water system; a fluid inlet configured to receive the sterilewater from the loop water system; a fluid outlet dispersing a firstfluid stream of the sterile water into a given area of the allograftprocessing field; the fluid outlet vertically offset at a distance fromequipment exposed to microbes of the allograft material being processedwithin the allograft processing field so as to prevent contamination andmicrobial wicking from the processing field to the circulatinghigh-purity water system.
 9. The water dispersion system of claim 8,wherein the fluid stream comprises a free fall of the sterile water fromthe fluid outlet into the given area of the allograft processing field.10. The water dispersion system of claim 9, further comprising aregulator valve associated with the fluid outlet, the regulator valveconfigured to provide a selectively-adjustable flow rate for the fluidstream.
 11. The water dispersion system of claim 8, wherein the fluidoutlet comprises a quick-connect stem and a fluid-delivery hose.
 12. Thewater dispersion system of claim 11, wherein the fluid-delivery hosecomprises a first end and a second end, the first end of thefluid-delivery hose fluidly coupled with the quick-connect stem, and thesecond end of the fluid-delivery hose extending toward the given area ofthe allograft processing field.
 13. The water dispersion system of claim8, wherein the fluid outlet is configured to prevent microbial wickingfrom the allograft processing field into the fluid outlet.